A trial looking at a new way of doing active surveillance for prostate cancer (IP9-ATLAS)
Cancer type:
Status:
Phase:
This trial is looking at 
and regular MRI scans for men having monitoring for prostate cancer.
Active surveillance is a way of taking care of prostate cancer that hasn’t spread outside the .
More about this trial
Prostate cancer can grow slowly and may never cause symptoms. Some people with localised prostate cancer have regular monitoring. This is active surveillance. It means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. You and your doctor can decide which treatment is best for you if it does start growing.
Active surveillance usually includes regular:
Researchers think that having regular MRI scans as part of the monitoring might help pick up earlier that the cancer has started to grow. This is when compared with the usual tests. They aren’t sure if this new way will be useful, so they are doing this trial to find out more.
In this trial, one group have the standard way of monitoring prostate cancer. And the other group have the newer way that includes PSA blood tests and regular MRI scans.
The main aims of the trial are to find out:
- which way of doing active surveillance works best to detect if the prostate cancer is growing
- how much having regular MRI scans costs
- if enough people are willing to take part
- how the different ways of doing surveillance affects quality of life
Please note, you might not get any benefit from taking part in this trial. But it might help people having active surveillance for prostate cancer in the future.
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have a prostate. You can take part if you are transgender (trans female) as long as you haven’t taken hormone treatment for this in the past. Your doctor will know about this.
- have been diagnosed with prostate cancer that is contained inside the prostate gland. This is localised prostate cancer.
- have had a type of MRI scan called a multiparametric MRI scan or biparametric MRI to help diagnose the cancer
- have had a tissue sample (
biopsy ) taken to diagnose your prostate cancer - have chosen to have active surveillance
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have been having active surveillance for more than 9 months before joining the trial
- can’t have an MRI or the
contrast medium you might have before the scan - have had both hips replaced
Trial design
This trial is taking place in the UK. The team need 1,263 people to take part.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. You have one of the following:
- standard active surveillance
- the newer way of doing active surveillance
Standard active surveillance group
You have regular check ups with your doctor and all of the following:
- a PSA blood test every 3 months
- a prostate examination once a year
You may have an MRI scan at 1 year if you have not had one before your prostate cancer diagnosis. The trial team will let you know about this.
New active surveillance group
You have regular check ups with your doctor.
If you have cancer that your doctor can see on an MRI scan or if the cancer has a medium risk of growing you have:
- a PSA blood test every 6 months and
- an MRI scan once a year for 5 years
If you have cancer that your doctor can’t see on an MRI scan and the cancer has a very low risk of growing you have:
- a PSA blood test every 6 months and
- an MRI scan at 1 year, 3 years and 5 years
Both groups
The tests and scans you have might show that there are signs that the cancer is getting worse. You then have a tissue sample () taken to confirm this. You may then need to have treatment depending on the result. This is part of your routine care. Your doctor will talk to you about the best treatment for you.
Quality of life
The trial team ask you to fill out some questionnaires:
- when you join the trial
- once a year for 5 years
- when the trial ends
The questionnaires ask about urine problems, problems with sex and how your bowels are working. They also ask how you are feeling. This is called a quality of life study.
The team also ask you to fill out some questionnaires about any side effects if you have an MRI or a need a tissue sample taken.
The questionnaires are on paper or you can do them online.
Hospital visits
You don’t have extra hospital visits if you are in the standard surveillance group.
In the new surveillance group, you have more hospital visits to have the MRI scans. You have between 3 and 5 extra visits depending on how often you have the scans.
Follow up
You continue with regular follow up with your healthcare team when the trial finishes. This is part of your routine care.
The team ask for your permission to check your health through national
UK NHS databases. They do this for up to 10 years after you join the trial. This helps the team to see how you are getting on and if you have started treatment for prostate cancer.
Side effects
An MRI scan is a safe test. If your MRI scan shows there might be cancer, the doctor will take a tissue sample (biopsy). Side effects of a biopsy might include:
- blood in the urine, poo or semen
- difficulty passing urine or a urine infection
- pain or discomfort
We have more information about having an MRI scan.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Hashim Ahmed
Supported by
Imperial College London
NIHR Health Technology Assessment (HTA) programme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
